Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT06082466
Eligibility Criteria:
Inclusion Criteria
* Age at least 18 years
* Informed consent form with signature
* Rutherford Category 3 (\<200m) or chronic critical ischemia (Rutherford Category 4-6)
* Assured inflow and recipient artery.
Exclusion Criteria
* Pregnant or breastfeeding women
* Active infection or sepsis
* Acute ischemia
* Endovascular procedure in the region to be treated.
* Vein with outer diameter \<3.5 mm or \>8 mm under pressure.
* Spliced Veins.
* Known allergy to the cobalt-chromium alloy (ASTM 1058) or its components (Cobalt-Chromium-Iron-Nickel-Molybdenum).
* Vasculitis
* Coagulopathy
* Radiation therapy near the anastomosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06082466
Study Brief:
Protocol Section:
NCT06082466